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Nutritional and Dietary Treatment Study for Children/Adults With Autism

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ClinicalTrials.gov Identifier: NCT02059577
Recruitment Status : Completed
First Posted : February 11, 2014
Last Update Posted : February 11, 2014
Sponsor:
Collaborator:
Autism Research Instittute
Information provided by (Responsible Party):
Arizona State University

Study Description
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Brief Summary:

70 children and adults with autism spectrum disorders will be enrolled in a 1-year, single-blind treatment study. Assessments will be conducted at the beginning and end of the study, including measurements of nutritional, metabolic, and digestive status and assessments of autism severity and overall functioning. Half of the participants will be randomized into a treatment study, and half will be randomized to no changes in their current treatments. Treatments will be added in a sequential manner over 12 months, including vitamin/minerals, essential fatty acids, carnitine, digestive enzymes, and healthy, gluten-free, casein-free diets. A dedicated team of nutritionists, nurses, and physicians will support and monitor the participants throughout the study.

A group of 50 neurotypical children and adults, of similar age and gender, will be included for comparison.


Condition or disease Intervention/treatment Phase
Autism Dietary Supplement: Nutritional and Dietary Interventions Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Nutritional and Dietary Treatment Study for Children/Adults With Autism
Study Start Date : November 2011
Actual Primary Completion Date : April 2013
Actual Study Completion Date : April 2013
Arms and Interventions
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Arm Intervention/treatment
Experimental: Treatment Group
This group received a combination of nutritional treatments, added sequentially, including vitamins/minerals, essential fatty acids, Epsom salt baths, carnitine, digestive enzymes, and healthy, gluten-free, casein-free diets.
 Dietary Supplement: Nutritional and Dietary Interventions
Day 0: Vitamin/Mineral supplementation begins. Day 30: Essential Fatty Acid supplementation begins. Day 60: Epsom Salt baths begin (2x/week) Day 90: Carnitine supplementation begins Day 180 Digestive Enzyme supplementation begins; Day 210: Healthy, casein-free, gluten-free diet is begun.
Other Names:
  • vitamin/mineral supplement
  • essential fatty acids
  • Epsom salt bath
  • carnitine
  • digestive enzymes
  • healthy gluten-free casein-free diet
No Intervention: Non-Treatment Group
This group did not have any significant changes in their treatments for 12 months


Outcome Measures
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Primary Outcome Measures :
  1. Childhood Autism Rating Scale [ Time Frame: 12 months ]
    Pre and post assessment of autism symptoms/severity

  2. Reynolds Intellectual Assessment Scales [ Time Frame: 12 months ]
    Pre and post test of intellectual ability

  3. Vineland Adaptive Behavior Scale [ Time Frame: 12 months ]
    Pre and post evaluation of adaptive behaviors


Eligibility Criteria
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Ages Eligible for Study:   30 Months to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Inclusion Criteria - Autism Group

  1. Diagnosis of autism spectrum disorder (autism, PDD-NOS, or Asperger's) by a psychiatrist, psychologist, or developmental pediatrician
  2. Verification of diagnosis by an ADOS evaluation (conducted by ASU staff)
  3. Age of 2.5 years to 60 years

Enrollment Criteria - Non-autism Group

  1. No diagnosed mental disorders, including autism spectrum disorders, ADHD, depression, anxiety, etc.
  2. No first-degree relatives of individuals with autism (no siblings or parents)
  3. Age of 2.5 years to 60 years -

Exclusion Criteria:

Exclusion Criteria - Autism Group

  1. Major changes in behavioral or medical treatments in the previous two months, or intention to make such changes during the 12 months of the study.
  2. Usage of nutritional supplements (vitamins, minerals essential fatty acids, carnitine) or special diets in the previous two months

Exclusion Criteria - Non-autism Group 1) Usage of nutritional supplements (vitamins, minerals essential fatty acids, carnitine) or special diets in the previous two months

-

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02059577


Locations
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United States, Arizona
Arizona State University
Tempe, Arizona, United States, 85284
Sponsors and Collaborators
Arizona State University
Autism Research Instittute
Investigators
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Principal Investigator: James B. Adams, PhD Arizona State University
More Information
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Responsible Party: Arizona State University
ClinicalTrials.gov Identifier: NCT02059577    
Other Study ID Numbers: NutritionDietAutism
First Posted: February 11, 2014    Key Record Dates
Last Update Posted: February 11, 2014
Last Verified: February 2014
Keywords provided by Arizona State University:
vitamins
minerals
essential fatty acids
Epsom salts
 carnitine
digestive enzymes
gluten-free casein-free diet
Additional relevant MeSH terms:
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Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders